Methodological considerations: Potency tests for recombinant adjuvanted RTS,S vaccine
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چکیده
There is currently no International Standard suitable for the standardization of assays of vaccines from the manufacturer. The manufacturer has therefore established a product-specific reference preparation which is traceable to a lot of vaccine shown to be efficacious in clinical trials. This vaccine will serve as a working standard and will be included in all potency tests. The NRA approves the reference preparation used and the potency limits applied. The performance of this reference vaccine should be monitored by trend analysis using relevant test parameters, and it should be replaced when necessary.
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